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Testimony on Regulation of Food Additives by Linda Suydam
Interim Deputy Commissioner for Operations
Food and Drug Administration
Public Health Service
U.S. Department of Health and Human Services

Before the House Committee on Government Reform and Oversight, Subcommittee on Human Resources and Intergovernmental Relations
June 22, 1996

Mr. Chairman:

I am pleased to be here today to provide information about the Food and Drug Administration's (FDA) regulation of food additives. Under the Federal Food, Drug, and Cosmetic Act (the Act), FDA is responsible for evaluating the safety and approving the use of food additives and color additives. In addition, FDA currently reviews petitions to affirm that substances used in food are generally recognized as safe (GRAS).

This statement addresses why the Agency reviews the safety of chemicals added to the food supply in the manner it does and identifies concerns that have been raised regarding the existing review process. It then outlines the comprehensive plan that FDA has devised to improve management of the overall program, reduce the inventory of pending petitions, and improve the timeliness and predictability of Agency decisions.

I. OVERVIEW

FDA's primary mission is to ensure that the food supply is safe for 280 million American consumers. Clearly, we have achieved this goal: the American food supply is one of the safest and most abundant in the world. The American public fully expects its food--including any substances added to food--to be safe, regardless of who consumes the food, the quantity consumed, or the period of time over which it is consumed. The requirement that chemical substances used as food additives be shown to be safe before they can be introduced into the food supply is a critical link in the food safety chain.

Approval of a food additive poses unique safety considerations for the Agency. Unlike drugs which are ingested for the significant therapeutic benefit they are intended to confer on the patient, food additives are eaten by everyone and, by definition, are not supposed to produce any pharmacological effect. They do not provide direct benefits that justify exposing consumers to risk. This is true even for food additives, such as artificial sweeteners, that may have a beneficial effect on the American diet. Even in the case of an artificial sweetener, for example, there are already safe and effective alternatives available to reduce caloric intake for anyone motivated to do so.

Other factors also contribute to the unique safety concerns related to food additives. A food additive potentially will be consumed by everyone in the population, including pregnant women, children, and the elderly. In addition, food additives are going to be consumed by healthy individuals and may be consumed for an entire lifetime.

Finally, when FDA approves use of a food additive, that approval is generic--it permits anyone to manufacture or use the additive (consistent with any existing patent protection), in conformance with the substance's identity, specifications, and conditions of use. unlike drugs or medical devices, a food additive regulation is not a product license limited to a single sponsor or manufacturer. Therefore, a food additive petition must contain information adequate to demonstrate that the additive is safe under each and every condition of use to be permitted and to identify issues that would require restrictions to ensure safety.

Food ingredients can be classified into four groups: 1) food additives; 2) color additives; 3) ingredients for which either FDA or the U.S. Department of Agriculture specifically authorized use prior to 1958, the so-called, "Prior Sanctioned Substances;" and 4) GRAS substances, that is, substances that are agreed upon as safe by the general scientific community on the basis of scientific evidence or that were marketed prior to 1958 and are considered GRAS because of a long history of safe use. Only food and color additives require premarket approval. Our focus today is on food additives, 1 of which there are two types: those intentionally added to foods (direct additives) and those that can be expected to become components of food unintentionally because of their use (indirect additives). This latter category includes components of food packaging materials which may migrate into the food. Food additives vary greatly in composition and may be consumed, in the aggregate, in amounts exceeding millions of pounds per year. 1 Unless otherwise noted, the term "food additive" in this statement applies to color additives also.

The Food Additives Amendment of 1958 and the Color Additive Amendments of 1960 require that chemicals that are going to be used in food are safe. The 1958 law was a milestone in that it required safety testing for chemicals used in foods prior to their use, and placed the burden for conducting that testing squarely on the industry. It was the clear intent of Congress in its drafting of the Food Additives Amendment to the Act that safety was to be the only consideration in the decision whether to authorize use of a food additive. The legislative history of the 1958 amendments defined the standard by which FDA is to measure the safety of additives. Congress stated that:

Safety requires proof of a reasonable certainty that no harm will result from the proposed use of an additive. It does not--and cannot--require proof beyond any possible doubt that no harm will result under any conceivable circumstance.

The Color Additive Amendments contain the identical safety standard.

FDA's review of an additive is not an attempt to determine the absolute harmlessness of any chemical substance, nor an attempt to establish that no harm will result under any conceivable circumstance. Rather, it is a scientific inquiry to determine, with reasonable certainty, that no harm will result from the proposed use of an additive. The statute requires that the Agency perform a thorough, careful review that will allow us credibly to support and defend our evaluation that the use of an additive will be safe.

The credibility of FDA's review is very valuable for food manufacturers. They can be secure in the knowledge that FDA evaluated ingredients in their products and in the packages in which they are sold, and determined that these materials will not be harmful to the public. FDA stands behind these manufacturers and supports the safety of their products. Furthermore, the credibility of the safety of the U.S. food supply and the safety of FDA permitted food ingredients is a boon to domestic food producers who engage in global trade.

As we stated at the outset, FDA's primary mission is to ensure the safety of the food supply. With that mission comes the very important obligation to review and render decisions on proposed new food additives expeditiously, and we acknowledge that we need to improve our performance in this regard. The U.S. food industry is entitled to timely and predictable decisions on food additive petitions. We are committed to improving the review process in order to provide those decisions, and to do this in a way that will not jeopardize food safety or the independence, integrity and credibility of the review process.

We have taken, therefore, a close look at our process for reviewing petitions and have developed a comprehensive plan to improve the efficiency and overall functioning of the food additive review program. We will describe the plan in greater detail later in the testimony, but in essence, it addresses improvements to the management of the program and new approaches for the review of petitions that we believe will reduce the numbers of pending petitions and ensure timely review of new submissions.

The major elements of the plan include:

• reorganization of FDA's Center for Food Safety and Applied Nutrition (CFSAN) to place petition review resources under one central manager;
  
  
• development and issuance of a "Threshold of Regulation" approach for indirect additives that meet specific criteria;
  
  
• performance goals to review petitions within defined time periods;
  
  
• reform of the GRAS regulatory process;
  
  
• additional Agency resources to reduce the inventory of pending petitions; and
  
  
• use of external scientific expertise to expedite the review of pending petitions;
  
  
• elimination or reduction of requirements for environmental assessments for many petitions; and
  
  
• expanded programs to help petitioners submit complete, sufficient submissions.

This plan represents our thoughtful--but practical--attempt to reach a goal of timely, predictable decisions on food additive petitions. We believe that implementation of this comprehensive plan as a whole will, in the long run, result in significant, long-term improvement. We have begun implementation of several components and already have seen positive results. For the plan to be fully successful, however, we will need the cooperation and assistance of the food industry. Presently, many petitions, when submitted, have shortcomings in the data needed to support a decision to approve the additive. Similarly, during FDA's review, the data in a petition too often are found to be of poor quality or inadequate. An example of this is when the data do not answer the particular questions that a study was designed to address. In the past, because of the competitive nature of the marketplace, the industry has been reluctant to have the Agency formally deny product petitions. Consistent with industry's preference, FDA's traditional policy for food additives has been to work very closely with each petitioner to develop data, including additional scientific studies if necessary, to resolve safety questions that arise. we do this instead of simply denying those petitions that lack adequate supporting data. The point is that while this cooperative process to correct deficiencies in a petition added to the review time, it also added significantly to the likelihood that an additive ultimately would be approved.

In short, we acknowledge that FDA can improve the process for reviewing petitions for food ingredients, and we affirm our commitment to providing industry with timely decisions. Nevertheless, we also must call upon the industry to ensure that the petitions submitted to the Agency are of adequate quality so as not to impede the timeliness of a final decision.

I would like to add one final note regarding resources in the Agency as a whole. Part of the difficulty of addressing program needs in a time of limited and dwindling resources has meant that the Agency had to make some hard choices regarding its internal priorities. Historically, FDA has committed significant resources to review the safety and effectiveness of drugs and medical devices. Although such products have some associated risks, they confer clear benefits to the health of the public. With management changes and additional resources in both the drugs and device programs, we have been able to improve our performance markedly. By applying some of the lessons we have learned in those two programs to the food additive process, we believe that we can achieve similar results.

II. THE AGENCY'S PLAN

FDA is committed to decreasing the time to a decision, and to reducing the pending inventory of active petitions, every bit as much as petitioners are. Our efforts to do so, however, must not compromise the safety of products entering the marketplace and must be fair to all petitioners. Indeed, FDA already has implemented changes to speed and improve the petition review process. A brief description of our comprehensive plan follows:

A. MANAGEMENT REFORMS

1. CFSAN Reorganization
   
   In November 1992, CFSAN was reorganized, placing most petition review resources under one central line management. Prior to this time, the former Division of Food and Color Additives had to coordinate review of chemistry and toxicology data with other offices under different directors. These other directors were responsible for programs other than petition review. Under the reorganized structure, the direct line authority of the Director of the Office of Premarket Approval over most personnel reviewing petitions provides for more effective and efficient oversight of the process and allows for more uniform alignment of priorities.
   
   
2. Special Focus Team for Complex Scientific Issues To assist in the review of petitions that present complex scientific or regulatory issues, FDA organized a Regulatory and Science Policy Board, composed of the senior management of the Office of Premarket Approval and other senior scientists from CFSAN or other parts of the Agency as needed. The board acts to resolve difficult scientific issues and to set policy for non-routine petitions and other food ingredient-related issues.
   
   
3. Increased Use of Other Scientists
   
   CFSAN is increasing its direct use in the petition review process of both non-federal scientists and research scientists from other Centers and agencies when CFSAN scientists lack specific expertise. Such scientists provide in-depth reviews and reports for the development of regulations and serve as consultants for the pre-market review process in CFSAN. For example, to resolve novel questions raised in the review of petitions to evaluate the use of fat substitutes, CFSAN requested assistance from clinical nutritionists at the U. S. Department of Agriculture (Beltsville), and from reviewers from FDA's Center for Veterinary Medicine to evaluate special animal studies in swine.
   
   The Agency also intends to increase significantly consultation with the Food Advisory Committee, especially for help in resolving complex scientific issues, such as those posed by novel food ingredients. For example, the Agency sought advice from the Committee regarding FDA's approach to regulating products developed using biotechnology.
   
   
4. Contract with the Federation of American Societies for Experimental Biology (FASEB)
   
   FDA has been criticized as being too conservative in making safety determinations and as requiring more testing than is necessary or appropriate. FDA has asked FASEB, under an existing contract, to consider these issues.
   
   A vexing issue for the Agency today is deciding how to reach a safety decision for food ingredients for which tests using traditional animal models may not be appropriate. For example, consumer interest in nutritionally modified diets has led to new food ingredients used in high amounts that replace or supplement common food components, principally, sugar or fat. In such situations, FDA has made safety judgments on a case-by-case basis, using criteria that it believed would be accepted by the community of food safety experts. FDA believes that some of its decisions have been delayed because of a lack of general agreement on the testing that is appropriate when traditional approaches may not resolve safety questions definitively. To address this, FDA also has asked FASEB to institute a study to make recommendations on, among other things, criteria that the scientific community would agree justify the use of alternative models to ensure the safety of food ingredients.

B. REDUCING THE PENDING INVENTORY OF PETITIONS

1. Increase Petition Review Staff
   
   A problem that contributes significantly to FDA's lengthy review time is the sizable inventory of pending petitions. Indeed, because of the queue of assignments on a particular reviewer's desk, it may take a long time before work on a newly submitted petition can begin. Studies from petitions submitted previously are "ahead" of the new petition and fairness to petitioners dictates that they be reviewed first.
   
   To reduce the backlog of pending petitions, the Agency is committing resources for the food additive process from other offices in CFSAN and other Centers, such as, the National Center for Toxicological Research. For example, research scientists may perform technical reviews of studies in pending petitions. We will make available no fewer than 22 FTE's from other programs over the next 6- 12 months for this effort.
   
   
2. Contracts
   
   Almost 150 of the approximately 290 pending petitions are for indirect additives (components of food packaging or other articles that come in contact with food). Generally, the testing requirements for many of these substances are standard and straightforward for which the Agency has well developed guidelines for the industry. Therefore, we expect to award a contract for independent third-party scientific review of some indirect additive petitions. Upon receipt of the results of the review, FDA will render the final safety decision and prepare the documents to approve the petition or, in the case that the petition is not approvable, to inform the petitioner of the reasons why.
   
   Similarly, for many direct food ingredients, there are often thousands of pages of data from studies carried out to assess the toxicity of the compound in animals. In order to expedite completion of the review of the pending direct food additive petitions and of the more complex pending indirect additive petitions, FDA will award a contract for review of specific types of studies--such as classical, standard toxicity studies, routinely submitted in support of both direct and indirect additive petitions. We believe that this will greatly speed our notification to a petitioner that the data in the petition support approval, or why the data do not support such a finding.
   
   These programs should assist us in reducing substantially the number of pending petitions. This, in turn, will improve our timeliness in reaching decisions on petitions of all types.

C. NEW APPROACHES TO PETITION REVIEW

The Agency believes that the expenditure of resources for review of a particular petition should be commensurate with the risk posed by the substance. To address petitions for low-risk situations, we have done the following:

1. "Threshold of Regulation" Policy
   
   Because of their low dietary exposure, many indirect additives are likely to pose relatively little risk to consumers. Because of the large number of petitions submitted for indirect food additives, however, FDA has had to expend a large amount of resources reviewing these petitions.
   
   FDA has implemented a "Threshold of Regulation" approach for indirect additives. In October 1993, FDA proposed this policy, which establishes a process for determining when the likelihood or extent of migration to food of a noncarcinogenic substance used in packaging is so trivial as not to require regulation of the substance as a food additive. Under this process, information about the proposed use of a noncarcinogenic substance that results in a dietary concentration that does not exceed the threshold would undergo an abbreviated review by FDA, as opposed to the extensive review and formal issuance of a regulation normally required for food additives.
   
   We have been implementing this policy on a limited basis, and in FY 1994, we issued 46 letters for substances that might otherwise have been the subject of food additive petitions. The final regulations implementing the Threshold of Regulation policy will be completed and published in the Federal Register soon.
   
   
2. Reinvention of GRAS Regulatory Process
   
   Unlike a food additive, a substance that is "generally recognized as safe" by qualified experts may be used lawfully in the absence of any FDA action. In part because of this distinction, and as part of President Clinton's and Vice President Gore's National Performance Review, FDA is proposing to replace the current regulatory process for reviewing the GRAS status of ingredients with a simple notification procedure. Under this process, FDA will have a brief period of time-- 60 to 90 days--to object to an independent GRAS determination reflected in a notification.
   
   
3. Expanding Criteria for Exclusion from a Requirement to Prepare are Environmental Assessments
   
   Under the National Performance Review, we also are proposing to eliminate or reduce requirements for environmental assessments for many routine petitions.
   
   
4. Policy for Food Biotechnology Products
   
   We created a process whereby the developer of a food product utilizing biotechnology (many such products present low risk) consults the Agency early on to discuss the product and identify potential safety and regulatory issues. This process allows the Agency to use its resources effectively to remain abreast of developments in the food biotechnology field and identify those cases in which premarket review and approval may be warranted. To date, the Agency has concluded the consultation process on approximately a dozen products.

D. PERFORMANCE GOALS

One of the industry's greatest concerns is that the Agency takes too long to inform petitioners that the information in a petition supports approval, or that the data are inadequate and clarification or more data are needed. A key lesson of the prescription drug user fee program has been the utility of establishing performance goals in managing the product review process. we believe the establishment of such goals for the food additive petition review process will serve to fulfill the Agency's commitment to timely and predictable decisionmaking over the long term. We are announcing that we will be establishing performance goals for the review of food additive petitions. Such goals can only become operative, however, once the backlog of pending petitions is reduced substantially and the other management review process improvements are implemented fully.

In considering the performance goals that we might set, we have classified petitions into one of three "tiers" based on length, complexity, or novelty of issues presented. These proposed response time goals will apply to new petitions received following full implementation of the comprehensive plan.

• TIER I petitions would include "routine" petitions of several classes: e.g., many indirect additive petitions, or subsequent approvals for an already approved additive where new issues do not arise. For these petitions, our goal is to issue an Agency response-- that the submission is adequate, or provide a complete description of why it is not adequate--within 90 days of receipt of the submission.
  
  
• TIER II includes petitions that do not pose novel scientific or regulatory issues, but which contain more data than a petition that would meet the criteria for Tier I. For these petitions, our goal is to issue an Agency response within 180 days of receipt of submission.
  
  
• TIER III includes petitions for additives that present difficult or novel scientific or regulatory and policy issues or either have wide exposure (such as an artificial sweetener) or high exposure (such as an additive used as a macro-ingredient). Petitions for such additives generally contain very numerous and/or very complex safety studies. For these petitions, our goal is to issue an Agency response within 360 days of submission.

We propose to phase in our accomplishment of these goals over three years, beginning one year after initiation of the contracts to reduce the backlog. For example, our goal is to act on 70 percent of new Tier I petitions within 90 days in the first year, 60 percent of new Tier II petitions within 180 days in the first year, and likewise, 50 percent of new Tier III petitions within the 360 day goal. A complete list of our goals is as follows:

We believe that full implementation of this program will respond to industry's major concern about the process: Decisions will be reached in a more timely manner, and with much greater predictability for petitioners. There is still much to be done, but once our plan has been completely phased in, we believe we will see additional speed and efficiency in our review process, while simultaneously preserving the integrity, credibility, and science base of that review, and, importantly, continuing to protect the public health.

E. WORKING WITH INDUSTRY

• PETITIONERS WORKSHOPS
  
  FDA has well-established guidelines for petitioners, for example, preparing chemistry data to measure migration of packaging materials, or information needed to determine exposure scenarios, etc. We also are exploring other ways to educate petitioners regarding development of petitions that are complete and sufficient. For example, we are planning a "Food Additive Petition Workshop" in conjunction with CFSAN's National Center for Food Safety and Technology in Chicago to be held in the fall; if successful, we will hold additional workshops.
  
  
• INDUSTRY PROPOSALS
  
  FDA is interested also in the "Industry Initiative for Food Additive Petitions," which has been proposed by Pfizer, Inc., together with a group of other food and food ingredient companies. The proposal aims to improve the quality of the data submitted to the Agency, thereby facilitating and potentially reducing FDA's review time. We believe elements of this proposal could be helpful both for FDA and for industry. We look forward to working with the industry to identify elements that will improve the process and simultaneously preserve the credibility and integrity of that process in keeping with the existing safety standard upon which the American public and the industry rely.

III. CONCLUSION

Mr. Chairman, the Agency is keenly aware that the food additive, color additive, and GRAS affirmation petition processes take too long. We have outlined and already begun to implement our comprehensive plan to remedy the situation. We are willing to work with the Committee and to consider other approaches that might further improve the efficiency of this program.

We strongly urge, however, that the zeal to speed up the process not be allowed to override the credibility and integrity of that process, nor to undermine consumers, confidence in the safety of the American food supply. American consumers and the food industry would be ill served if food safety is sacrificed simply because of a desire for a speedy review of petitions. Consumers expect safety and industry relies upon FDA's careful scientific decisions regarding the safety of food ingredients. We do not want either of those to be compromised.